# K032300: Accolade-J Hip Stem Series

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Oct 9, 2003 after 76 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Accolade TMZF HA Hip Stems: named in the summary without a submission number
- (no number) Accolade TMZF HA Plus Hip Stems: named in the summary without a submission number
- (no number) Omnifit M-HA Hip Stems: named in the summary without a submission number

## Most influential descendants
- K162125: MALUC™ Total Hip Arthroplasty System (2017), 0 descendants of its own

## Recalls of this device
- Mar 1, 2011 · Not classified · Z-2557-2011: Accolade TMZF Plus Hip Stems are being recalled due to grit blast media which was observed in the drive hole.

## Indications for use
The subject hip stems are single-use devices intended for cementless fixation. They are intended for primary reconstruction of the proximal feinur or revision total hip arthroplasty. These devices are intended for use with any currently available Nowniedica Osteonics acetabular component and V40° femoral heads labeled for use with V40° Titanium stems. ‘The indications for use remain identical to those of the predicate devices, and are restated here for ease of reference. Non-in tlamnia to ry dege ne ra t i ve j o i n t d i sea se i nc 1ud i ng osteoar t 11r i t is and a vascu 1a 1- nec sos i s, Rheumatoid arthritis, Correction of functional deformity, Revision procedures where other treatments or devices have failed, Treatment of nonunion, and femoral neck and trochanteric fractures of the proxiinal feinur with head involvement that are unmanageable using other techniques.

Source page: https://510kreport.com/device/K032300
Methodology: https://510kreport.com/methodology